N/A
N=79
Patient Perception of Visual Distortions
Cataract · Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT02203747 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Visual Distortion Symptoms — 0.89; 0.38; 0.64; 0.38 rating of visual distortion symptoms
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Administration of patient self-assessment (Other)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Optics
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Distortion Symptoms |
0.82; 0.65; 0.64; 0.38; 0.64; 0.47 | — |
| PRIMARY Visual Distortion Symptoms |
0.82; 0.65; 0.64; 0.38; 0.64; 0.47 | — |
Summary
The purpose of this study is to evaluate visual distortions reported by pseudophakic patients.
Eligibility Criteria
Inclusion Criteria
- Corneal astigmatism of at least 0.75 diopters
- Bilaterally-implanted with monofocal toric intraocular lenses in both eyes or with monofocal non-toric intraocular lenses in both eyes
- At least one month postoperative from second-eye surgery
- Ability to understand, read and write English to give consent and complete study questionnaire
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and study visits
- Sign informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
- Other protocol-defined inclusion criteria may apply
Exclusion Criteria
- Any ocular pathology of clinical significance, as determined by the investigator, other than regular corneal astigmatism, that may affect visual outcomes or influence subjective ocular visual symptoms
- Patient is pregnant or is lactating
- Participation in any other clinical trial during the last 30 days prior to study enrollment or concurrent participation in any other ongoing clinical trial
- Other protocol-defined exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02203747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.